Wheat-based products especially wheat flours and derivatives from wheat flours cause adverse health conditions in a minor but significant proportion of the human population.
Wheat allergy is well documented, less severe than allergies to several other food allergens and mediated via an IgE-mediated response to wheat protein. Wheat-based products can neither be consumed or applied topically to avoid an allergic response.
Coeliac Disease has been recognised in children failing to thrive and persists through adulthood. It has been shown to be a genetically-determined autoimmune condition stimulated by the consumption of wheat protein (gluten) causing the lining of the small intestine to be eroded and lose its digestive and nutrient absorptive capacity. A gluten-free diet for persons so affected is necessary throughout life and many such gluten-free foods are now available suitable for persons with Coeliac Disease.
Less-well-defined food intolerance has been attributed to wheat-based foods amongst others. Symptoms include feelings of abdominal discomfort, bloating and flatus are often referred to as Irritable Bowel Syndrome (IBS); these have been attributed to abnormal response to fermentation of ingested foods in the distil part of the small intestine and proximal region of the large intestine of the gastrointestinal tract. Avoidance of certain foods including wheat-based products often remedies the physiological condition. Desirable foods without-wheat derived ingredients such as gluten-free breads have been formulated with flours from rice, corn (maize) and cassava as described in Lopex et al (2004) (A C B Lopez, A J G Pereira and R G Junqueira (2004) Flour mixture of Rice Flour, Corn and Cassava starch in the production of gluten-free bread. Brazilian Arch Biol Technol 47; 63-70.)
In 2005 Gibson and Shepherd (R. R. Gibson & S. J. Shepherd (2005) Personal view: food for thought—western lifestyle and susceptibility to Crohn's disease. The FODMAPS hypothesis. Aliment. Pharmacol. Ther. 21, 1399-1409.) proposed a new hypothesis by which excessive delivery of highly fermentable but poorly absorbed short-chain carbohydrates and polyols which they designated FODMAPS—Fermentable Oligosaccharides, Disaccharides, Monosaccharides And PolyolS—to the distil small intestinal lumen induced abnormal conditions in the bowel.
A diet with increasing evidence of efficacy for the management of IBS is the low FODMAPS diet described by Gibson & Shepherd (2010) (Gibson, P. R and Shepherd, S. J. (2010) Evidence-based dietary management of functional gastrointestinal symptoms: the FODMAPS approach. J Gastroenterol Hepatol. 25: 252-258). In healthy individuals such fermentation may indeed be advantageous to gut health but to those with IBS, fermentation of FODMAPS should be avoided to the greatest extent possible by careful diet selection; the quantity present may vary greatly between different food sources. The list of foods with a high content of FODMAPS includes wheat flour and products made with it, which has led to popular recognition of a health condition referred to as wheat intolerance or more specifically Non-Coeliac Gluten Sensitivity (NCGS).
Biesiekierski et al (2011) (Biesiekierski, J. R., Newnham, E. D., Irving, P. M., Barrett, J. S., Haines, M., Doecke, J. D., Shepherd, S. J., Muir, J. G. and Gibson, P. R. (2011) Gluten causes gastrointestinal symptoms in subjects without celiac disease: a double blind randomised placebo-controlled trial Am. J. Gastroenterol 106, 508-514) reported that after many dietary tests that some non-coeliacs experienced pain and bloating after eating foods containing gluten and concluded that Non-Coeliac Gluten Intolerance (Sensitivity) may exist. This prompted a proliferation in gluten-free foods in the marketplace.
According to a recent multi-authored review by Carlo Catassi et al available as an open access article www.ncbi.nlm.nih.gov/pmc/articles/PMC3820047, Non Coeliac Gluten Sensitivity: The New Frontier of Gluten Related Disorders, the frequency of NCGS is still unclear and an overlap between NCGS and IBS has been detected. Lack of biomarkers is still a major limitation of clinical studies making it difficult to differentiate NCGS from other gluten related disorders.
However, in a complete reversal of their conclusions in Biersiekierski et al (2011), more recently Biesiekierski et al (2013) (Biesiekierski, J R, Peters, S. L., Newnham, E. D., Rosella, O, Muir, J. G. and Gibson P. R. (2013) Gastroenterology 145(2) 320-328) showed no effects of gluten intolerance in patients with self-reported non-celiac gluten sensitivity after dietary reduction of fermentable, poorly absorbed, short-chain carbohydrates. In a placebo-controlled, cross-over rechallenge study, they found no evidence of specific or dose-dependent effects of gluten in patients with NCGS placed on diets low in FODMAPS.
Understanding of FODMAPS encompasses mechanisms of action, being luminal distension from their osmotic effect as described by Barrett et al (2010) (Barrett, J. S, Gearry, R. B, Muir, J. G, Irving, P. M, Rose, R, Rosella, O, Haines, M. L, Shepherd, S. J, and Gibson, P. R. (2010) Dietary poorly absorbed, short-chain carbohydrates increase delivery of water and fermentable substrates to the proximal colon. Aliment Pharmacol Ther 31:874-882) together with rapid fermentation preferentially to hydrogen as described by Ong et al (2010) (Ong, D. K, Mitchell, S. B, Barrett, J. S, Shepherd, S. J, Irving, P. M, Biesiekierski, J. R, Smith, S, Gibson, P. R. and Muir, J. G. (2010) Manipulation of dietary short chain carbohydrates alters the pattern of gas production and genesis of symptoms in irritable bowel syndrome L Gastroenerol Hepatol. 25:1366-1373).
These findings together with support of continually expanding food compositional analysis, have led to widespread application of the low-FODMAPS diet to manage IBS symptoms throughout Australia and New Zealand and in some parts of Europe and North America. In a controlled, cross-over study of patients with IBS by Halmos et al (2014) (Emma P. Halmos, Victoria A. Power, Susan J Shepherd, Peter R Gibson and Jane G. Muir (2014) A diet low in FODMAPS reduces symptoms of Irritable Bowel Syndrome. Gastroenterol 146: 67-75), demonstrated that a diet low in FODMAPS effectively reduced functional gastrointestinal symptoms.
Consequently, we have recognised a significant opportunity that could provide benefit commercially and socially. It is estimated that approximately 14% of western consumers used to eating bread and other wheat-based products exhibit or develop wheat intolerance. By the present invention, food products containing wheat gluten protein are made tolerable for those normally wheat intolerant by provision of ingredients that meet medically established criteria for low-FODMAPS content.
Understanding of what low-FODMAPS in a food means analytically appears not to be precise and may relate to individual response to dietary FODMAPS intake. Shepherd et al (2008) (Shepherd S. J., Parker, F C, Muir J G and Gibson P R Dietary triggers of abdominal symptoms in patients with Irritable Bowel Syndrome; randomised placebo-controlled evidence. Clin Gastroenterol. Hepatol 6, 765-711) established baseline (low-FODMAPS) diets with daily quantities of fructans (FODMAPS) in the range 1.1-2.7 g.
Gibson & Shepherd (2010) (Gibson, P R and Shepherd S J (2010) Evidence-based dietary management of functional gastrointestinal symptoms: the FODMAP approach. J Gastroenterol Hepatol. 25, 252-268) considered >0.2 g of fructans (FODMAPS) per serve at risk of inducing symptoms.
Halmos et al (2014) (Halmos E P, Power, V A, Shepherd S J, Gibson P R & Muir J G A diet low in FODMAPS reduces symptoms of Irritable Bowel Syndrome Gastroenterol 146, 67-75) described low FODMAP as <0.5 g FODMAPS per sitting and in the Mean Daily Nutrition Information tabulated therein for the Low FODMAP diet the Total FODMAPS were reported as 3.05 (1.86-4.25) g.
Monash University Department of Gastroenterology and Translational Nutrition have set a level of less than or equal to 0.3 g FODMAPS per serve for Low-FODMAPS foods (Monash University Analytical Report 2014) however, a defining level for FODMAPS content in flours and ingredients has not been published.
The fructan content of breads varies considerably according to Whelan et al (2011), (Whelan, K, Abrahmsohn, O, David, G J, Staudacher H, Irving, P, Lower M C and Ellis, P R (2011) Fructan content of commonly consumed wheat, rye and gluten-free breads. Int J Food Sci Nutr 62(5), 498-503) with a range of 0.61-1.94 g fructan/100 g bread.
As aforesaid, gluten-free foods have proliferated recently in response to predominantly self-diagnosed wheat intolerance such foods being substantially formulated using flours from rice or corn (maize). Consequently low-FODMAPS WGPF should preferably have a FODMAPS content less than or equal to that of corn or rice flours to be sufficiently low so as not to result in wheat intolerance. The fructan (FODMAPS) content of maize is reported as 0.6 g/100 g by Knudsen (1997) (KEB Knudsen (1997) Carbohydrate and lignin contents of plant materials used in animal feeding. Animal Feed Sci Technol 67; 319-338) which is a little higher than that for rice flour (see Example 1. Table 1).
Modern methods of food technology combined with advanced food analysis enable components of food source materials to be separated or isolated and used either directly as food ingredients or nutraceuticals or combined as required to prepare special foods to meet particular dietary or health outcomes.
Processing liquid food source materials such as milk into its multiple components at high purity for nutriceutical application is greatly advanced through developments in separation technologies especially centrifugation, membrane technologies and ion exchange processes. By comparison, separation and purification of components from cereal sources such as wheat flour has been slower for dietary and health advantage due to the complexity of the composition and the physical and chemical properties of the components that render them difficult to separate from each other and purify to the extent required for nutriceutical purposes.
Wheat flour is unique amongst widely consumed cereal flours in that it contains protein which when mixed with water in a dough or batter or when extracted from the flour with abundance of water forms a complex known as wheat gluten. This wheat gluten protein (WGP) complex has unique physical and chemical properties that are demonstrated as well-documented, characteristic visco-elastic properties. These protein properties of viscous strength combined with elasticity independent of other components of flour uniquely allow a cohesive dough or batter to be formed which can be expanded by inclusion of a gas usually carbon dioxide generated by a fermentation process or a chemical reaction or can be processed into various non-expanded cohesive forms. When such doughs or batters containing wheat gluten protein in various formulations as have been prepared over thousands of years and documented in cookery and recipe books in many languages through recent history are cooked by a variety of means in a range of configurations, products arising are often deemed highly desirable as food items.
The composition of wheat flour has been modified or augmented for purposes of changing the functional performance of dough made from it or for improving the nutritional value. For such purposes wholly or partially reconstituted and recombined flours have been described but these purposes are different from the purpose of the present invention.
US Patent Application 2009252844 discloses the formation of a partially reconstituted high fibre wheat flour by dry combining a low-moisture-content fibre source into the host/carrier in an amount which provides a substantially homogeneous mixture throughout and dry blending into a homogeneous mixture one grain-based binder and a grain-based tenderiser. The use of such partially reconstituted wheat flour in pasta is disclosed. The invention provides for nutritionally improved reconstituted wheat flour with higher fibre content but does not consider the FODMAP content of the flour or teach reconstituted wheat flour for the wheat intolerant.
U.S. Pat. No. 8,372,466 discloses a recombined whole grain flour for use in preparing whole grain products such that the whole grain particulates provide minimum visual impact to the whole grain product. By selectively controlling the particle size of the milled bran and germ constituents used in the recombined whole grain flour the visual and colour impact associated with bran and germ particulates can be substantially eliminated from the whole grain product. The invention provides a process for a more visually acceptable whole grain reconstituted flour but does not consider the FODMAP content of the flour or teach reconstituted wheat flour for the wheat intolerant.
US Patent Application No 20120196013 discloses a combined stabilised bran component and stabilised whole grain wheat flour produced by subjecting a bran enriched coarse fraction which contains bran, germ and starch to grinding or milling to reduce grittiness of the coarse fraction without substantially damaging the starch due to abrasion. The invention provides a process for improving the texture of a reconstituted high fibre wheat flour but does not consider the FODMAP content of the flour or teach reconstituted wheat flour for the wheat intolerant.
The increase in incidence of obesity particularly in western populations has driven progress towards foods considered less likely to promote weight gain and obesity. Higher protein content and lower carbohydrate content in foods and in the diet have been advocated for such health benefit and inventions have been disclosed for this purpose which is different from the purpose of the present invention.
US Patent Application 20050129823 discloses the composition and method for making high-protein and low carbohydrate food products. This is achieved for advantage in baked goods and extruded food products by substituting wheat flour wholly or in part by a combination of starch that is resistant to amylase digestion and proportions of various protein-rich ingredients selected from wheat gluten, devitalised wheat gluten, deamidated wheat gluten, and hydrolysed wheat gluten. Additionally fibre-rich and other ingredients were utilised to prepare a wide range of foods demonstrated in 54 Examples. Of these, all except four contained in their formulations a proportion of wheat flour; of the four, two contained no starch, a third contained soy products and a fourth product contained a polyol. However, the invention predates the FODMAP hypothesis and is directed towards a different purpose. No consideration is given to the FODMAP content of the individual ingredients or to total FODMAPS content of food formulations exemplified or their suitability for wheat intolerant persons. FODMAPS contents would be considerable due to the contents of wheat flour or other FODMAP-containing ingredients. Consequently, food products made by the process of the invention would not be suitable for persons with wheat intolerance nor does the invention lead or direct one skilled in the art towards the product and process of the present invention.
U.S. Pat. No. 4,255,518 discloses a process of water recycling in the wet milling of cereal relating to the recovery of starch from corn, wheat, rice, milo and the like.
U.S. Pat. No. 4,412,867A discloses wet milling of starch bearing materials including corn wheat and potatoes with water recycle after reverse osmosis or ultrafiltration in order to reduce the water requirement of the milling process.
US Patent Application 2006008568 discloses a low carbohydrate bread product prepared by using a bread dough substantially free of wheat flour. A wheat starch, a wheat protein isolate and a soluble fibre are mixed into a dough and baked. The purpose of the invention was to produce a low carbohydrate content in a bread product to meet a dietary perception that less carbohydrate and more protein and fibre provided dietary advantage. The objects of this invention are thus completely different issue and addressed a different health problem than the issue addressed in the present invention. US Patent Application 2006008568 predates the FODMAP hypothesis and consequently does not consider the FODMAP content of the ingredients and the suitability of the bread product for wheat intolerant persons.
Further in US Patent Application 2006008568 the principal ingredients are (1) a commercial wheat starch product separated from a wheat flour which within commercial separation limitations according to modern manufacturing practice would be substantially washed free of gluten and (2) a commercial gluten product separated from a wheat flour which within commercial separation limitations according to modern manufacturing practice would be substantially reduced in starch content relative to the ratio of starch to gluten in the parent flour, Such starch and gluten products however have not been analysed in this disclosure for FODMAPS content and in any event could not be inherently low-FODMAPS because of the limitations of said known commercial manufacturing practices.
Gluten protein product, commercially as vital wheat gluten, is typically manufactured at 75% protein content (N %×5.7) and sometimes, after more vigorous separation processes, at 80% protein, these compositions reflecting the degree of difficulty in removing fine particles of starch and fibre from a visco-elastic gluten mass. Consequently, 20-25% of the gluten product is not protein but residual fat, starch, fibre and other components of flour entrapped within the visco-elastic mass. Because of the difficulty of separating the gluten protein from non-gluten components of flour known commercial manufacturing adopts procedures that utilise recycling of aqueous extracts within the manufacturing plant to conserve total water usage. This however would not produce sufficiently low FODMAPS products to meet the specific dietary needs of wheat intolerant persons.
Consequently there is no information in any of the above prior art documents either singly or in combination which discloses, suggests or teaches the current invention of the applicant.